FDA 510(k) Applications Submitted by Kevin Ni

FDA 510(k) Number Submission Date Device Name Applicant
K190941 04/10/2019 BioCardia 8.5 F Avance Steerable lntroducer BioCardia, Inc.
K980308 01/27/1998 ECHOTECH 3D FREESCAN ECHOTECH 3D IMAGING SYSTEMS GMBH
K990560 02/22/1999 LIFE IMAGING SYSTEMS, MODEL L3DI LIFE IMAGING SYSTEMS, INC.
K081512 05/30/2008 STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE MEDTRONIC NAVIGATION, INC.
K992931 08/31/1999 NON-STICK BIPOLAR FORCEPS SILVERGLIDE SURGICAL TECHNOLOGIES
K013088 09/17/2001 ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS ECHOTECH 3D IMAGING SYSTEMS, INC.
K963807 09/23/1996 TOMTEC ECHO-SCAN TOMTEC IMAGING SYSTEMS, INC.
K242791 09/16/2024 Electric wheelchair (KR-8807) Zhejiang Kairui Medical Device Co., Ltd.


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